A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate Safety and Feasibility of the FieldForce™ Ablation System in Symptomatic Patients With Ventricular Arrhythmia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Safety Endpoint Acute
研究概览
简要总结
This is a prospective safety and feasibility study to evaluate the safety of the FieldForce™ Ablation system in patients with ventricular arrhythmia divided into two groups: VT (VCAS-I) and frequent premature ventricular complex (VCAS-II).
详细描述
Summary:
Ventricular arrythmias are common but often undertreated. The most effective pharmacologic management and implantable devices are used to treat deadly arrythmias like ventricular tachycardia (VT) and ventricular fibrillation (VF). However, the efficacy of antiarrhythmic drugs (AADs) has been proven to be low, and implantable cardioverter defibrillators (ICDs) treat VT but do not prevent it. Prospective trials demonstrate that VT ablation is by far the most effective therapy for ventricular tachycardia and in some cases it is curative. Despite overwhelming evidence that catheter ablation is superior, there are many technical barriers that prevent widespread application of this therapy. Furthermore, non-fatal ventricular arrythmias such as premature ventricular contractions (PVCs) are treatable by catheter ablation. The technical challenges facing VT and PVC ablations are similar as current technologies are optimized to treat atrial arrythmias often at the expense of performance in the ventricle.
Pulsed field ablation (PFA) is a new ablation method for the therapy of arrhythmias. PFA is considered as a non-thermal and low-energy method of ablation. This technique is characterized by pulse trains of short-duration and high-voltage electrical impulses that result in electric field-mediated tissue injury. The very strong electric fields put strain on cellular compartmentalization. These changes can be reversible, and cells can recover with no consequences; however, if compartmentalization is disrupted for an extended period of time, it results in metabolic injury and cell death. This mechanism is also known as electroporation. Different cell types are sensitive to these types of insults leading to tissue selectivity in the heart. Clinical studies have already demonstrated the feasibility and safety of PFA for the treatment of atrial fibrillation. However, there is less data on the application of PFA for VT.
Therefore, this Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation aims to evaluate Safety and Feasibility of the FieldForce™ Ablation system in patients with ventricular tachycardia divided into two groups: ventricular tachycardia (VCAS-I) and unifocal premature ventricular complex (VCAS-II).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed patient informed consent form (ICF).
- •Female and male participants between 18 and 80 years.
- •For VCAS-I group, patients with VT meeting class II-a/b indications in European guideline for catheter ablation, with a clinical VT event detected by an implanted ICD
- •For VCAS-II group, patients with frequent premature ventricular complexes (PVCs) meeting class II-a/b indications based on European guidelines for catheter ablation.
- •For VCAS-II, documentation of frequent PVCs by 24 hours Holter with >15% PVC burden for asymptomatic patients and >5% PVC burden for symptomatic patients within the last 60 days.
排除标准
- •Body Mass Index >
- •Pacemaker dependence.
- •Ineligible for ablation according to Physician judgement (including but not limited to known to have protruding left ventricular thrombus or have implanted mechanical aortic and mitral valves).
- •Recent MI (less than 90 days) or another reversible cause of VT (e.g., electrolyte abnormalities, drug-induced arrhythmia).
- •The presence of inferior vena cava embolic protection filter devices.
- •Recent cardiac surgery (less than 2 months)
- •NYHA Class IV.
- •Hemodynamically severe valvular disease that precludes ablation. Severity will be evaluated by using echocardiography, according to AHA and European guidelines.
- •Uncontrolled abnormal bleeding and/or clotting disorder.
- •Contraindication to systemic or oral anticoagulation.
- •Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or therapy, or confound data or its interpretation, including but not limited to solid organ or hematologic transplant, or currently being evaluated for an organ transplant.
- •Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea.
- •Chronic renal insufficiency of eGFR< 30 mL/min/1.73 m
- •Active malignancy
- •Untreated clinically significant infection.
- •Life expectancy is less than one year.
- •Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the study requirements.
- •Prohibitively distorted cardiac anatomy due to congenital heart disease.
- •Had a recent percutaneous coronary intervention (<1 month).
- •Participation in another investigational study or treatment with any investigational drug within the previous 30 days that would interfere with this study.
- •Patient is not able to understand the nature of this study or is unwilling or unable to attend the study procedures.
- •Pregnancy or breastfeeding
研究组 & 干预措施
Ventricular Tachycardia (VCAS-I)
Patients with ventricular tachycardia meeting class II-a/b indications in European guideline for catheter ablation, with a clinical VT event detected by an implanted ICD
干预措施: FieldForce™ Ablation System Ventricular Tachycardia (Device)
Premature Ventricular Contractions (VCAS-II)
For VCAS-II group, patients with symptomatic frequent unifocal premature ventricular complexes (PVCs) meeting class II-a/b indications based on European guidelines for catheter ablation. For VCAS-II, documentation of frequent PVCs by 24 hours Holter with >15% PVC burden for asymptomatic patients and >5% PVC burden for symptomatic patients within the last 60 days.
干预措施: FieldForce™ Ablation System Premature Ventricular Contractions (Device)
结局指标
主要结局
Safety Endpoint Acute
时间窗: < 30 days
device-related or procedure-related Serious Adverse Events
次要结局
- Procedure duration (average minutes of procedure time)(1 day)
- Detect Ischemic scar homogenization (VCAS-I)(baseline and 90 days)
- Evaluate VT inducibility (VCAS-I) pre and post ablation(index procedure)
- Reduction in clinical arrhythmia burden (VCAS-I)(baseline, 90 days & 180 days)
- Reduction in clinical arrhythmia burden (VCAS-II)(baseline, after 90 days and no longer than 120 days)